There are over seven million diagnostic and therapeutic coronary interventions performed each year. By far, the majority of these interventions are performed using percutaneous puncture of the femoral artery to gain access to the arterial system.
Once the intervention is concluded, the vascular puncture site has to be sealed to prevent bleeding, while natural healing processes close the puncture site. Conventional management of the puncture site has typically involved external compression using, e.g., digital pressure, C-clamps, or sandbags, followed by immobilization and bedrest. Proper placement of compression devices to stop bleeding calls for trained clinical skills. Likewise, strong nursing skills are required to monitor for rebleeding. The patient can suffer local discomfort, which may exceed the pain associated with the diagnostic or therapeutic procedure requiring vascular access in the first instance. Complications are not uncommon, which can lead to prolonged hospitalization, transfusion, and direct surgical repair of the puncture site.
Various alternative methods for sealing a vascular puncture site have been tried. For example, collagen plugs have been used to occlude the puncture orifice. The collagen plugs are intended to activate platelets and accelerate the natural healing process. Holding the collagen seals in place using an anchor located inside the artery has also been tried. Still, patient immobilization is required until clot formation stabilizes the site. Other problems, such as distal embolization of the collagen, rebleeding, and the need for external pressure to achieve hemostatis, also persist.
As another example, devices that surgically suture the puncture site percutaneously have also been used. The devices require the practice of fine surgical skills to place four needles at a precise distance from the edges of the puncture orifice and to form an array of suture knots, which are tightened, resulting in puncture edge apposition.
There remains a need for fast and straightforward mechanical and chemical systems and methods to close vascular puncture sites and to accelerate the patient's return to ambulatory status without pain and prolonged immobilization.